⚠️ Warnings
Before travelling across time zones, the patient should consult their physician. Travelling across time zones may mean that the patient will need to use insulin and take meals at different times. Hyperglycaemia
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetics, may lead to hyperglycaemia and diabetic ketoacidosis. The first symptoms of hyperglycaemia usually develop gradually over a period of hours or days. They include thirst, frequent urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite, and acetone odour on the breath. In type 1 diabetes, untreated hyperglycaemic events may lead to diabetic ketoacidosis, which can be fatal.
Hypoglycaemia
Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia.
Hypoglycaemia may occur if the insulin dose is too high relative to the insulin requirement. In the event of hypoglycaemia or suspected hypoglycaemia, Actraphane must not be administered. After the patient's blood glucose level has stabilised, dose adjustment must be considered (see sections 4.8 and 4.9).
Patients whose glycaemic control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia. Patients should be informed accordingly. In patients who have had diabetes for a long time, the usual warning symptoms may disappear.
Concomitant illness, particularly infections and febrile conditions, usually increases the patient's insulin requirement. Concomitant illness of the kidneys, liver, or disease affecting the adrenal glands, pituitary gland, or thyroid gland may require changes in insulin dose.
If the patient is transferred to another type of insulin medicinal product, the early warning signs of hypoglycaemia may change or be attenuated compared to those experienced with the previous insulin.
Transfer from other insulin medicinal products
Transferring a patient to another type or brand of insulin must be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin, or insulin analogue) and/or method of manufacture (recombinant DNA production versus animal-sourced insulin) may result in the need for a change in dosage. Patients transferred to Actraphane from other types of insulin may require an increased number of daily injections or a change in dose compared with those used with their previous insulin medicinal products. If dosage adjustment is necessary, it may be made with the first dose or during the first several weeks or months.
Injection site reactions
As with any insulin therapy, injection site reactions may occur, manifested as pain, redness, urticaria, inflammation, bruising, swelling, and itching. Regular rotation of the injection site within a given area reduces the risk of these reactions. Reactions usually resolve within a few days to a few weeks. In rare cases, injection site reactions may require discontinuation of Actraphane.
Skin and subcutaneous tissue disorders
Patients must be instructed to continuously rotate the injection site to reduce the risk of lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injection into sites with these reactions. Cases have been reported where a sudden change of injection site to an unaffected area resulted in hypoglycaemia. Blood glucose monitoring is recommended after changing the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medicinal products may be considered.
Combination of Actraphane with pioglitazone
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, particularly in patients with risk factors for the development of cardiac failure. This should be taken into account if treatment with pioglitazone in combination with Actraphane is considered. If this combination is used, patients must be monitored for signs and symptoms of cardiac failure, weight gain, and oedema. Pioglitazone must be discontinued if any deterioration in cardiac symptoms occurs.
Prevention of accidental mix-ups/medication errors
Patients must be instructed to check the insulin label before each injection to avoid accidental mix-ups between Mixtard and other insulin products.
Traceability
To improve the traceability of biological medicinal products, the name of the administered product and the batch number should be clearly recorded.
